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FDA 510(k)

syngo.CT Extended Functionality

K-Number: K192402 · 2019-09-20

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-09-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Extended Functionality is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K192402. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo.CT Extended Functionality?

syngo.CT Extended Functionality is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K192402.

When did syngo.CT Extended Functionality receive FDA 510(k) clearance?

syngo.CT Extended Functionality received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192402.

Who is the listed applicant for syngo.CT Extended Functionality?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo.CT Extended Functionality?

The FDA product code for syngo.CT Extended Functionality is JAK.

Other records listing Siemens Medical Solutions USA, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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